HIV InfectionsPhase 2NCT02475655
Evaluating the Safety and Tolerability of Ruxolitinib in Antiretroviral-Treated HIV-Infected Adults
A Phase 2 study testing Ruxolitinib in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 14 sites in United States.
Trial summary
The purpose of this study was to evaluate the safety and tolerability of ruxolitinib in HIV-positive adults who were virologically suppressed and who were on antiretroviral therapy (ART). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Ruxolitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 14 sitesUnited States
- Study dates
- 16 May 2016to 4 Apr 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-1 infection
- CD4+ T cell count greater than 350 cells/mm^3 within 45 days prior to study entry
- Documented virologic suppression defined as HIV-1 RNA level below the limit of quantification (eg, less than 40, less than 50, or less than 75 copies/mL, depending on the assay) using an FDA-approved assay with a quantification limit of 75 copies/mL or lower for at least 48 weeks prior to study entry
- Screening HIV-1 RNA level below the limit of quantification
- Tuberculosis (TB) screening within 365 days of the screening visit diagnosed by tuberculin skin test or interferon gamma release assay
- Currently on continuous ART for at least 730 days prior to study entry, defined as continuous ART for the 730 days period, inclusive, prior to study entry with no ART interruption longer than 7 consecutive days. NOTE: The current regimen must include TDF/FTC, TAF/FTC, TDF+3TC, or ABC/3TC; plus a nonnucleoside reverse transcriptase inhibitor or integrase strand transfer inhibitor (NNRTI or INSTI, not containing cobicistat) for at least 60 days, inclusive, prior to study entry.
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- The following laboratory values obtained within 45 days prior to entry:
- Absolute neutrophil count (ANC) greater than or equal to 1,000/mm^3
- Hemoglobin greater than 12.0 g/dL for men and greater than 11.0 g/dL for women
- Platelets greater than or equal to 140,000/mm^3
- Calculated creatinine clearance (CrCl) greater than or equal to 70 mL/min (by Cockcroft Gault equation)
- Aspartate aminotransferase (AST) (SGOT) less than or equal to 1.5x upper limit of normal (ULN)
- Alanine aminotransferase (ALT) (SGPT) less than or equal to 1.5x ULN
- Alkaline phosphatase less than or equal to 1.5x ULN
- For females of reproductive potential, a negative serum or urine pregnancy test with a sensitivity of 25 mIU/mL within 72 hours, inclusive, prior to study entry
- All participants must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization)
- All participants of reproductive potential, who were participating in sexual activity that could lead to pregnancy, must agree to use at least one reliable method of contraception while receiving the study drugs and for 7 weeks after stopping the medications
- Ability and willingness of participant or legal representative to provide written informed consent and attend study visits as scheduled at a participating site
Who cannot join
- A current or past history of progressive multifocal leukoencephalopathy
- Breastfeeding or pregnancy
- Use of strong inhibitors or inducers of CYP3A4 including a protease inhibitor, cobicistat or entry inhibitors as part of the current ART regimen or other concomitant therapy
- Known allergy/sensitivity or any hypersensitivity to components of study drug or their formulation
- Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
- Acute or serious illness or infection requiring systemic treatment and/or hospitalization within 60 days prior to entry
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- Vaccinations (other than influenza) less than or equal to 45 days prior to the study entry visit.
- Use of immunomodulators (e.g., interleukins, interferons, cyclosporine), systemic cytotoxic chemotherapy or investigational therapy less than or equal to 60 days prior to study entry
- Any current diagnosis or past history of a significant cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, neuropsychiatric, psychiatric, or other serious illness that, in the opinion of the investigator, could constitute a risk when taking investigational product or could interfere with the interpretation of data or affect the participant's ability to participate in the study. Diagnoses that would lead to exclusion include, but were not limited to the following:
- CDC category C AIDS-indicator conditions
- NOTE A: Except HIV encephalopathy, HIV wasting, esophageal candidiasis, or pneumocystis pneumonia without dissemination.
- NOTE B: List available: http://www.cdc.gov/mmwr/preview/mmwrhtml/00018871.htm
- Herpes zoster (dermatomal or non-dermatomal).
- NOTE C: A history of prior chickenpox was not exclusionary.
- Lymphoproliferative malignancy
- Chronic liver disease of any etiology and any degree of severity
- Chronic hepatitis, except for hepatitis C that has been cured (defined as a Sustained Virologic Response, which is an undetectable HCV-RNA at 12 weeks or more after completing treatment measured by a sensitive, qualitative, or quantitative HCV-RNA assay)
- Disseminated fungal infection of any type or duration that is not limited to cutaneous or mucocutaneous surfaces
- A medical disorder that predisposes to bleeding
- Change in the ART regimen within 12 weeks, inclusive, prior to study entry or intended modification of ART during the study.
- History of untreated latent tuberculosis infection (LTBI) diagnosed by tuberculin skin test or interferon gamma release assay. LTBI treatment would consist of 9 months of isoniazid or an equivalent therapy completed at least 4 weeks prior to study entry.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Alabama CRS
Birmingham, Alabama, 35294
Northwestern University CRS
Chicago, Illinois, 60611
Cincinnati Clinical Research Site
Cincinnati, Ohio, 45219
Case Clinical Research Site
Cleveland, Ohio, 44106
UCLA CARE Center CRS
Los Angeles, California, 90035
Vanderbilt Therapeutics (VT) CRS
Nashville, Tennessee, 37204
Weill Cornell Chelsea CRS
New York, New York, 10010
Weill Cornell Uptown CRS
New York, New York, 10065
Penn Therapeutics, CRS
Philadelphia, Pennsylvania, 19104
The Miriam Hospital Clinical Research Site (TMH CRS) CRS
Providence, Rhode Island, 02906
University of Rochester Adult HIV Therapeutic Strategies Network CRS
Rochester, New York, 14642
UCSD Antiviral Research Center CRS
San Diego, California, 92103
Ucsf Hiv/Aids Crs
San Francisco, California, 94110
Washington University Therapeutics (WT) CRS
St Louis, Missouri, 63110-1010
About this study
Official title: A Randomized, Pilot Study of Ruxolitinib in Antiretroviral-Treated HIV-Infected Adults
The purpose of this study was to evaluate the safety and tolerability of ruxolitinib in HIV-positive adults who were virologically suppressed and who were on antiretroviral therapy (ART).
Read the detailed description
Ruxolitinib is a medication approved by the U.S. Food and Drug Administration (FDA) to treat myelofibrosis, a disorder in which bone marrow is replaced by scar (fibrosis) tissue. Many of the cytokines affected by myelofibrosis are also affected by HIV. Because of this, ruxolitinib may also be a possible treatment for HIV. The purpose of this study was to evaluate the safety and tolerability of ruxolitinib in HIV-positive adults who were on ART and who were virologically suppressed. Researchers evaluated the effect ruxolitinib had on inflammation and immune activation.
This study enrolled HIV-positive adults who were on select ART regimens and who had viral suppression. ART was not provided by the study; participants continued to receive ART from their own health care providers. Participants were randomly assigned to receive either ruxolitinib (Arm A) or no study treatment (Arm B) in 2:1 ratio. Participants in Arm A received ruxolitinib twice a day for 5 weeks. All participants attended study visits at entry (Day 0) and Weeks 1, 2, 4, 5, 10, and 12. These visits included physical examinations, clinical assessments, blood collection, adherence assessments, oral swab collection, and pregnancy testing for female participants. At Weeks 1 and 4, participants in Arm A took part in pharmacokinetic (PK) sampling, which involved having blood drawn several times over 6 to 8 hours.
- Conditions
- HIV Infections
- Being tested
- Ruxolitinib
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RuxolitinibDrug
10 mg orally twice daily for 5 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Ruxolitinib | Experimental | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Receives: Drug: Ruxolitinib |
| Arm B: No Study Treatment | No intervention | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants on the Ruxolitinib Arm Who Experienced Any Safety Milestone Events While On-Treatment
Events defined as safety milestones are listed below and together makeup the composite endpoint.
- Confirmed CD4+ decline > 33% of entry and to < 350 cell/mm^3 (for participants with entry CD4+ T cell count < 700 cells/mm^3)
- Confirmed CD4+ decline > 50% of entry (for participants with entry CD4+ T cell count ≥ 700 cells/mm^3)
- Confirmed HIV-1 RNA level above the lower limit of quantification in the absence of an interruption of ART
- New or recurrent CDC category C AIDS-indicator condition
- HIV-1 associated infection including Herpes zoster
- Lymphoproliferative malignancies
- Grade 4 or recurrence of Grade 3 anemia/neutropenia
- New diagnosis of pneumonia, sepsis, or bacteremia
- Discontinuation of Ruxolitinib due to thrombocytopenia
- Any Grade 4 or recurrence of Grade 3 toxicity related to study drug
Percent experiencing a safety milestone will be reported.
Measured: Entry to Week 5
Percentage of Participants Who Experienced Any Safety Milestones On-study From Entry to Week 5
Events defined as safety milestones are listed below and together makeup the composite endpoint.
- Confirmed CD4+ decline > 33% of entry and to < 350 cell/mm^3 (for participants with entry CD4+ T cell count < 700 cells/mm^3)
- Confirmed CD4+ decline > 50% of entry (for participants with entry CD4+ T cell count ≥ 700 cells/mm^3)
- Confirmed HIV-1 RNA level above the lower limit of quantification in the absence of an interruption of ART
- New or recurrent CDC category C AIDS-indicator condition
- HIV-1 associated infection including Herpes zoster
- Lymphoproliferative malignancies
- Grade 4 or recurrence of Grade 3 anemia/neutropenia
- New diagnosis of pneumonia, sepsis, or bacteremia
- Occurrence of Grade 2 or higher thrombocytopenia
- Any Grade 4 or recurrence of Grade 3 toxicity
Percent experiencing a safety milestone will be reported.
Measured: Entry to Week 5
Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 5
Events defined as safety milestones are listed below.
- Confirmed CD4+ decline > 33% of entry and to < 350 cell/mm^3 (for participants with entry CD4+ T cell count < 700 cells/mm^3)
- Confirmed CD4+ decline > 50% of entry (for participants with entry CD4+ T cell count ≥ 700 cells/mm^3)
- Confirmed HIV-1 RNA level above the lower limit of quantification in the absence of an interruption of ART
- New or recurrent CDC category C AIDS-indicator condition
- HIV-1 associated infection including Herpes zoster
- Lymphoproliferative malignancies
- Grade 4 or recurrence of Grade 3 anemia/neutropenia
- New diagnosis of pneumonia, sepsis, or bacteremia
- Occurrence of Grade 2 or higher thrombocytopenia
- Any Grade 4 or recurrence of Grade 3 toxicity
Percent experiencing each safety milestone will be reported. Safety milestone categories are not mutually exclusive.
Measured: Entry to Week 5
Number of Participants With Premature Discontinuation of Study Treatment in the Ruxolitinib Arm
Number of participants with premature discontinuation of study treatment are summarized.
Measured: Entry to Week 5
Fold Change in the Level of Plasma Interleukin 6 (IL-6) From Baseline to Week 4/5
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.
Baseline is defined as the geometric mean of the Pre-entry and Entry values. Week 4/5 is defined as the geometric mean of the Week 4 and Week 5 values. Fold change was calculated as the value at Week 4/5 divided by the value at Baseline.
Measured: Pre-entry, Entry, Weeks 4 and 5
Secondary outcomes (68)
Percentage of Participants on the Ruxolitinib Arm Who Experienced Any Safety Milestone Events During Total Follow-up
Events defined as safety milestones are listed below and together makeup the composite endpoint.
- Confirmed CD4+ decline > 33% of entry and to < 350 cell/mm^3 (for participants with entry CD4+ T cell count < 700 cells/mm^3)
- Confirmed CD4+ decline > 50% of entry (for participants with entry CD4+ T cell count ≥ 700 cells/mm^3)
- Confirmed HIV-1 RNA level above the lower limit of quantification in the absence of an interruption of ART
- New or recurrent CDC category C AIDS-indicator condition
- HIV-1 associated infection including Herpes zoster
- Lymphoproliferative malignancies
- Grade 4 or recurrence of Grade 3 anemia/neutropenia
- New diagnosis of pneumonia, sepsis, or bacteremia
- Discontinuation of Ruxolitinib due to thrombocytopenia
- Any Grade 4 or recurrence of Grade 3 toxicity related to study drug
Percent experiencing a safety milestone will be reported.
Measured: Entry to Week 12
Percentage of Participants Who Experienced Any Safety Milestones On-study From Entry to Week 12
Events defined as safety milestones are listed below and together makeup the composite endpoint.
- Confirmed CD4+ decline > 33% of entry and to < 350 cell/mm^3 (for participants with entry CD4+ T cell count < 700 cells/mm^3)
- Confirmed CD4+ decline > 50% of entry (for participants with entry CD4+ T cell count ≥ 700 cells/mm^3)
- Confirmed HIV-1 RNA level above the lower limit of quantification in the absence of an interruption of ART
- New or recurrent CDC category C AIDS-indicator condition
- HIV-1 associated infection including Herpes zoster
- Lymphoproliferative malignancies
- Grade 4 or recurrence of Grade 3 anemia/neutropenia
- New diagnosis of pneumonia, sepsis, or bacteremia
- Occurrence of Grade 2 or higher thrombocytopenia
- Any Grade 4 or recurrence of Grade 3 toxicity
Percent experiencing a safety milestone will be reported.
Measured: Entry to Week 12
Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 12
Events defined as safety milestones are listed below.
- Confirmed CD4+ decline > 33% of entry and to < 350 cell/mm3 (for participants with entry CD4+ T cell count < 700 cells/mm3)
- Confirmed CD4+ decline > 50% of entry (for participants with entry CD4+ T cell count ≥ 700 cells/mm3)
- Confirmed HIV-1 RNA level above the lower limit of quantification in the absence of an interruption of ART
- New or recurrent CDC category C AIDS-indicator condition
- HIV-1 associated infection including Herpes zoster
- Lymphoproliferative malignancies
- Grade 4 or recurrence of Grade 3 anemia/neutropenia
- New diagnosis of pneumonia, sepsis, or bacteremia
- Occurrence of Grade 2 or higher thrombocytopenia
- Any Grade 4 or recurrence of Grade 3 toxicity
Percent experiencing each safety milestone will be reported. Safety milestone categories are not mutually exclusive.
Measured: Entry to Week 12
Number of Participants Who Experienced a Protocol-defined Reportable Adverse Event at Any Post-entry Time Point.
Protocol-defined reportable adverse events include: all diagnoses regardless of grade, Grade 3 or higher sign/symptoms or laboratory values, any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. See the Protocol Section References for links to the EAE manual.
This is a subset of the events reported in the Adverse Events section.
Measured: Entry to Week 12
Creatinine Clearance
Creatinine clearance was calculated using the Cockcroft Gault equation. The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.
Measured: Entry, Weeks 1, 2, 4, 5, 10, and 12
Change in Creatinine Clearance Values From Entry
Creatinine clearance was calculated using the Cockcroft Gault equation. The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.
Absolute change was calculated as the value at Week 1/2 minus the value at Entry, the value at Week 4/5 minus the value at Entry, and the value at Week 10/12 minus the value at Entry.
Measured: Entry, Weeks 1, 2, 4, 5, 10, and 12
Creatinine
The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.
Measured: Entry, Weeks 1, 2, 4, 5, 10, and 12
Change in Creatinine Values From Entry
The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.
Absolute change was calculated as the value at Week 1/2 minus the value at Entry, the value at Week 4/5 minus the value at Entry, and the value at Week 10/12 minus the value at Entry.
Measured: Entry, Weeks 1, 2, 4, 5, 10, and 12
Absolute Neutrophil Count (ANC)
The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.
Measured: Entry, Weeks 1, 2, 4, 5, 10, and 12
Change in Absolute Neutrophil Count (ANC) Values From Entry
The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.
Absolute change was calculated as the value at Week 1/2 minus the value at Entry, the value at Week 4/5 minus the value at Entry, and the value at Week 10/12 minus the value at Entry.
Measured: Entry, Weeks 1, 2, 4, 5, 10, and 12
Hemoglobin
The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.
Measured: Entry, Weeks 1, 2, 4, 5, 10, and 12
Change in Hemoglobin Values From Entry
The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.
Absolute change was calculated as the value at Week 1/2 minus the value at Entry, the value at Week 4/5 minus the value at Entry, and the value at Week 10/12 minus the value at Entry.
Measured: Entry, Weeks 1, 2, 4, 5, 10, and 12
Platelet Count
The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.
Measured: Entry, Weeks 1, 2, 4, 5, 10, and 12
Change in Platelet Counts From Entry
The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.
Absolute change was calculated as the value at Week 1/2 minus the value at Entry, the value at Week 4/5 minus the value at Entry, and the value at Week 10/12 minus the value at Entry.
Measured: Entry, Weeks 1, 2, 4, 5, 10, and 12
Aspartate Aminotransferase (AST) (SGOT)
The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.
Measured: Entry, Weeks 1, 2, 4, 5, 10, and 12
Change in Aspartate Aminotransferase (AST) (SGOT) Values From Entry
The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.
Absolute change was calculated as the value at Week 1/2 minus the value at Entry, the value at Week 4/5 minus the value at Entry, and the value at Week 10/12 minus the value at Entry.
Measured: Entry, Weeks 1, 2, 4, 5, 10, and 12
Alanine Aminotransferase (ALT) (SGPT)
The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.
Measured: Entry, Weeks 1, 2, 4, 5, 10, and 12
Change in Alanine Aminotransferase (ALT) (SGPT) Values From Entry
The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.
Absolute change was calculated as the value at Week 1/2 minus the value at Entry, the value at Week 4/5 minus the value at Entry, and the value at Week 10/12 minus the value at Entry.
Measured: Entry, Weeks 1, 2, 4, 5, 10, and 12
Fold Change in the Level of Plasma Interleukin 6 (IL-6)
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.
Baseline is defined as the geometric mean of the Pre-entry and Entry values. Week 4/5 is defined as the geometric mean of the Week 4 and Week 5 values. Week 10/12 is defined as the geometric mean of the Week 10 and Week 12 values. Fold change was calculated as the value at Week 10/12 divided by the value at Baseline and the value at Week 4/5 divided by the value at Week 10/12.
Measured: Pre-entry, Entry, Weeks 4, 5, 10 and 12
Fold Change in the Level of Soluble CD14 (sCD14)
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.
Baseline is defined as the geometric mean of the Pre-entry and Entry values. Week 4/5 is defined as the geometric mean of the Week 4 and Week 5 values. Fold change was calculated as the value at Week 4/5 divided by the value at Baseline, the value at Week 12 divided by the value at Baseline, and the value at Week 12 divided by the value at Week 4/5.
Measured: Pre-entry, Entry, Weeks 4, 5, and 12
Change in CD4+ T Cell Count
Baseline is defined as the average of pre-entry and entry. Absolute change was calculated as the value at Week 2 minus the value at Baseline, the value at week 5 minus the value at baseline, the value at week 12 minus the value at baseline, and the value at week 5 minus the value at week 12.
Measured: Pre-entry, Entry, Weeks 2, 5, and 12
Number of Participants With Plasma HIV-1 RNA Level Above the Limit of Quantification
Participants were required to be virally suppressed, with a plasma HIV-1 RNA level below 40 copies/mL. The number of participants with plasma HIV-1 RNA level above the limit of quantification is reported at each time point.
Measured: Entry, Weeks 2, 5, and 12
Relative Risks of HIV-1 RNA by Single Copy Assay (SCA) < 0.4 Copies/mL
HIV-1 RNA was measured via Single Copy Assay Using Primer in Integrase (iSCA), results were reported as below or above the assay limit of detection (LOD) (LOD = 0.4 copies/mL). GEE models for binary data were used to calculate the relative risk of having HIV-1 RNA by iSCA <0.4 copies/mL (Week 5 compared to Entry, Week 12 compared to Entry, and Week 12 compared to Week 5).
Measured: Entry, Weeks 5 and 12
Fold Change in the Level of Plasma Tumor Necrosis Factor Alpha (TNF Alpha)
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.
Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry.
Measured: Entry, Weeks 5 and 12
Fold Change in the Level of Plasma Interleukin 1 Beta (IL-1 Beta)
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.
Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry.
Measured: Entry, Weeks 5 and 12
Fold Change in the Level of Plasma Interleukin 7 (IL-7)
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.
Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry.
Measured: Entry, Weeks 5 and 12
Fold Change in the Level of Interleukin 1 Alpha (IL-1 Alpha)
Laboratory testing was not performed so the data are not available.
Measured: Pre-entry, Entry, Weeks 4, 5, and 12
Fold Change in the Level of Interferon Gamma-induced Protein 10 (IP-10)
Laboratory testing was not performed so the data are not available.
Measured: Pre-entry, Entry, Weeks 4, 5, and 12
Fold Change in the Level of Macrophage Colony-stimulating Factor
Laboratory testing was not performed so the data are not available.
Measured: Pre-entry, Entry, Weeks 4, 5, and 12
Fold Change in the Level of Neopterin
Data not available because the testing lab reported that the values were unreliable.
Measured: Pre-entry, Entry, Weeks 4, 5, and 12
Fold Change in the Level of Plasma Interleukin 10 (IL-10)
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.
Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry.
Measured: Entry, Weeks 5 and 12
Fold Change in the Level of Plasma Interleukin 15 (IL-15)
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.
Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry.
Measured: Entry, Weeks 5 and 12
Fold Change in the Level of Plasma Interleukin 18 (IL-18)
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.
Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry.
Measured: Entry, Weeks 5 and 12
Fold Change in the Level of Plasma Transforming Growth Factor Beta 1 (TGF Beta-1)
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.
Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry.
Measured: Entry, Weeks 5 and 12
Fold Change in the Level of Plasma Transforming Growth Factor Beta 2 (TGF Beta-2)
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.
Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry.
Measured: Entry, Weeks 5 and 12
Fold Change in the Level of Plasma Transforming Growth Factor Beta 3 (TGF Beta-3)
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.
Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry.
Measured: Entry, Weeks 5 and 12
Change in (CD3+CD4+) CD38+HLADR+
Absolute change in the percent of parent cells (CD4+) that express CD38+HLADR+ cells (cellular marker of immune activation and inflammation in the peripheral blood).
Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Measured: Entry, Weeks 5 and 12
Change in (CD3+CD8+) CD38+HLADR+
Absolute change in the percent of parent cells (CD8+) that express CD38+HLADR+ cells (cellular marker of immune activation and inflammation in the peripheral blood).
Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Measured: Entry, Weeks 5 and 12
Change in (CD3+CD4+) CD25hi+
Absolute change in the percent of parent cells (CD4+) that express CD25hi+ cells (cellular marker of immune activation and inflammation in the peripheral blood).
Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Measured: Entry, Weeks 5 and 12
Change in (CD3+CD8+) CD25+
Absolute change in the percent of parent cells (CD8+) that express CD25+ cells (cellular marker of immune activation and inflammation in the peripheral blood).
Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Measured: Entry, Weeks 5 and 12
Change in (CD3+CD4+) CD127+
Absolute change in the percent of parent cells (CD4+) that express CD127+ cells (cellular marker of immune activation and inflammation in the peripheral blood).
Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Measured: Entry, Weeks 5 and 12
Change in (CD3+CD8+) CD127+
Absolute change in the percent of parent cells (CD8+) that express CD127+ cells (cellular marker of immune activation and inflammation in the peripheral blood).
Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Measured: Entry, Weeks 5 and 12
Change in (CD3+CD4+) Ki67+
Absolute change in the percent of parent cells (CD4+) that express Ki67+ cells (cellular marker of immune activation and inflammation in the peripheral blood).
Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Measured: Entry, Weeks 5 and 12
Change in (CD3+CD8+) Ki67+
Absolute change in the percent of parent cells (CD8+) that express Ki67+ cells (cellular marker of immune activation and inflammation in the peripheral blood).
Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Measured: Entry, Weeks 5 and 12
Change in (CD3+CD4+) Bcl2+
Absolute change in the percent of parent cells (CD4+) that express Bcl2+ cells (cellular marker of immune activation and inflammation in the peripheral blood).
Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Measured: Entry, Weeks 5 and 12
Change in (CD3+CD8+) Bcl2+
Absolute change in the percent of parent cells (CD8+) that express Bcl2+ cells (cellular marker of immune activation and inflammation in the peripheral blood).
Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Measured: Entry, Weeks 5 and 12
Change in (CD3+CD4+) a4b7+
Absolute change in the percent of parent cells (CD4+) that express a4b7+ cells (cellular marker of immune activation and inflammation in the peripheral blood).
Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Measured: Entry, Weeks 5 and 12
Change in (CD3+CD8+) a4b7+
Absolute change in the percent of parent cells (CD8+) that express a4b7+ cells (cellular marker of immune activation and inflammation in the peripheral blood).
Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Measured: Entry, Weeks 5 and 12
Change in (CD3+CD4+) CX3CR1+
Absolute change in the percent of parent cells (CD4+) that express CX3CR1+ cells (cellular marker of immune activation and inflammation in the peripheral blood).
Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Measured: Entry, Weeks 5 and 12
Change in (CD3+CD8+) CX3CR1+
Absolute change in the percent of parent cells (CD8+) that express CX3CR1+ cells (cellular marker of immune activation and inflammation in the peripheral blood).
Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Measured: Entry, Weeks 5 and 12
Change in CD69
Data not available because the team decided they were no longer clinically relevant, so samples were not tested for CD69.
Measured: Entry, Weeks 5 and 12
Change in PAR-1
Data not available because the team decided they were no longer clinically relevant, so samples were not tested for PAR-1.
Measured: Entry, Weeks 5 and 12
Change in Classical Monocytes (CD14+CD16-)
Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Measured: Entry, Weeks 5 and 12
Change in Classical Monocytes (CD14+CD16-) Expressing CD163+
Absolute change in the percent of classical monocytes (CD14+CD16-) that express CD163+.
Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Measured: Entry, Weeks 5 and 12
Change in Classical Monocytes (CD14+CD16-) Expressing CCR2+
Absolute change in the percent of classical monocytes (CD14+CD16-) that express CCR2+.
Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Measured: Entry, Weeks 5 and 12
Change in Classical Monocytes (CD14+CD16-) Expressing CX3CR1+
Absolute change in the percent of classical monocytes (CD14+CD16-) that express CX3CR1+.
Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Measured: Entry, Weeks 5 and 12
Change in Inflammatory Monocytes (CD14+CD16+)
Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Measured: Entry, Weeks 5 and 12
Change in Inflammatory Monocytes (CD14+CD16+) Expressing CD163+
Absolute change in the percent of inflammatory monocytes (CD14+CD16-) that express CD163+.
Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Measured: Entry, Weeks 5 and 12
Change in Inflammatory Monocytes (CD14+CD16+) Expressing CCR2+
Absolute change in the percent of inflammatory monocytes (CD14+CD16+) that express CCR2+.
Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Measured: Entry, Weeks 5 and 12
Change in Inflammatory Monocytes (CD14+CD16+) Expressing CX3CR1+
Absolute change in the percent of inflammatory monocytes (CD14+CD16+) that express CX3CR1+.
Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Measured: Entry, Weeks 5 and 12
Change in Patrolling Monocytes (CD14dimCD16+)
Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Measured: Entry, Weeks 5 and 12
Change in Patrolling Monocytes (CD14dimCD16+) Expressing CD163+
Absolute change in the percent of patrolling monocytes (CD14dimCD16+) that express CD163+.
Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Measured: Entry, Weeks 5 and 12
Change in Patrolling Monocytes (CD14dimCD16+) Expressing CCR2+
Absolute change in the percent of patrolling monocytes (CD14dimCD16+) that express CCR2+.
Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Measured: Entry, Weeks 5 and 12
Change in Patrolling Monocytes (CD14dimCD16+) Expressing CX3CR1+
Absolute change in the percent of patrolling monocytes (CD14dimCD16+) that express CX3CR1+.
Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Measured: Entry, Weeks 5 and 12
Fold Change in Cellular HIV-1 DNA
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.
Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry.
Measured: Entry, Weeks 5 and 12
Fold Change in Cellular HIV-1 Total RNA
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.
Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry.
Measured: Entry, Weeks 5 and 12
Percentage of Participants With Detectable CMV Shedding
Level of CMV shedding was summarized by study week and arm as the percentage of those above and below the assay limit of detection.
Detectable CMV shedding was defined as CMV level > 0 copies/ml of elution. The percentage of participants with detectable CMV at any on-treatment time point (ever shedding at weeks 1, 2, 4, or 5) and any post-treatment time point (ever shedding at weeks 10 or 12) was contrasted between study arms.
Measured: Pre-entry, Entry, and Weeks 1, 2, 4, 5, 10, and 12
Ruxolitinib Systemic Clearance (CL/F) From 2-compartment Pharmacokinetic (PK)
Ruxolitinib plasma concentrations were fitted to a population 2-compartment distribution model, assuming first-order input, distribution and elimination from the plasma compartment, using nonlinear mixed-effects modeling software. We estimated parameter geometric means and proportional variabilities between subjects (IIV when feasible) and the variability in drug absorption between occasions (IOV week 1 and week 4/5), and related distribution volumes to body weight.
Measured: Week 1 and, Week 4/5; blood samples were drawn pre-dose and at 1-1.5, 2.5-4, 4-6, and 6-8 hours post-dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study start16 May 2016
- Primary completion18 Feb 2018
- Study completion4 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Vincent Marconi, MD, Study chair, Emory UniversityJeffrey Lennox, MD, Study chair, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02475655
- Sponsor's protocol ID
- A5336
- Other IDs
- 11977
- Status last verified
- Jul 2020
- First submitted
- 16 Jun 2015
- Last updated
- 4 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Marconi VC, Moser C, Gavegnano C, Deeks SG, Lederman MM, Overton ET, Tsibris A, Hunt PW, Kantor A, Sekaly RP, Tressler R, Flexner C, Hurwitz SJ, Moisi D, Clagett B, Hardin WR, Del Rio C, Schinazi RF, Lennox JJ. Randomized Trial of Ruxolitinib in Antiretroviral-Treated Adults With Human Immunodeficiency Virus. Clin Infect Dis. 2022 Jan 7;74(1):95-104. doi: 10.1093/cid/ciab212.
PubMed 33693561
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Pilot Study of Ruxolitinib in Antiretroviral-Treated HIV-Infected Adults
- ClinicalTrials.gov ID
- NCT02475655
- Acronym / sponsor ID
- A5336
- Conditions
- HIV Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 16 May 2016 (actual)
- Primary completion
- 18 Feb 2018 (actual)
- Study completion
- 4 Apr 2018 (actual)
- First posted
- 19 Jun 2015 (estimated)
- Results
- Posted 18 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate the safety and tolerability of ruxolitinib in HIV-positive adults who were virologically suppressed and who were on antiretroviral therapy (ART).
Detailed description
Ruxolitinib is a medication approved by the U.S. Food and Drug Administration (FDA) to treat myelofibrosis, a disorder in which bone marrow is replaced by scar (fibrosis) tissue. Many of the cytokines affected by myelofibrosis are also affected by HIV. Because of this, ruxolitinib may also be a possible treatment for HIV. The purpose of this study was to evaluate the safety and tolerability of ruxolitinib in HIV-positive adults who were on ART and who were virologically suppressed. Researchers evaluated the effect ruxolitinib had on inflammation and immune activation.
This study enrolled HIV-positive adults who were on select ART regimens and who had viral suppression. ART was not provided by the study; participants continued to receive ART from their own health care providers. Participants were randomly assigned to receive either ruxolitinib (Arm A) or no study treatment (Arm B) in 2:1 ratio. Participants in Arm A received ruxolitinib twice a day for 5 weeks. All participants attended study visits at entry (Day 0) and Weeks 1, 2, 4, 5, 10, and 12. These visits included physical examinations, clinical assessments, blood collection, adherence assessments, oral swab collection, and pregnancy testing for female participants. At Weeks 1 and 4, participants in Arm A took part in pharmacokinetic (PK) sampling, which involved having blood drawn several times over 6 to 8 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Ruxolitinib | Experimental | Drug: RuxolitinibParticipants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
| Arm B: No Study Treatment | No intervention | –Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- HIV-1 infection
- CD4+ T cell count greater than 350 cells/mm^3 within 45 days prior to study entry
- Documented virologic suppression defined as HIV-1 RNA level below the limit of quantification (eg, less than 40, less than 50, or less than 75 copies/mL, depending on the assay) using an FDA-approved assay with a quantification limit of 75 copies/mL or lower for at least 48 weeks prior to study entry
- Screening HIV-1 RNA level below the limit of quantification
- Tuberculosis (TB) screening within 365 days of the screening visit diagnosed by tuberculin skin test or interferon gamma release assay
Key exclusion criteria (21 listed)
- A current or past history of progressive multifocal leukoencephalopathy
- Breastfeeding or pregnancy
- Use of strong inhibitors or inducers of CYP3A4 including a protease inhibitor, cobicistat or entry inhibitors as part of the current ART regimen or other concomitant therapy
- Known allergy/sensitivity or any hypersensitivity to components of study drug or their formulation
- Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ruxolitinib10 mg orally twice daily for 5 weeks | Drug | Arm A: Ruxolitinib |
Primary outcome
Percentage of Participants on the Ruxolitinib Arm Who Experienced Any Safety Milestone Events While On-Treatment
Time frame: Entry to Week 5
Events defined as safety milestones are listed below and together makeup the composite endpoint. * Confirmed CD4+ decline > 33% of entry and to < 350 cell/mm^3 (for participants with entry CD4+ T cell count < 700 cells/mm^3) * Confirmed CD4+ decline > 50% of entry (for participants with entry CD4+ T cell count ≥ 700 cells/mm^3) * Confirmed HIV-1 RNA level above the lower limit of quantification in the absence of an interruption of ART * New or recurrent CDC category C AIDS-indicator condition * HIV-1 associated infection including Herpes zoster * Lymphoproliferative malignancies * Grade 4 or recurrence of Grade 3 anemia/neutropenia * New diagnosis of pneumonia, sepsis, or bacteremia * Discontinuation of Ruxolitinib due to thrombocytopenia * Any Grade 4 or recurrence of Grade 3 toxicity related to study drug Percent experiencing a safety milestone will be reported.
Percentage of Participants Who Experienced Any Safety Milestones On-study From Entry to Week 5
Time frame: Entry to Week 5
Events defined as safety milestones are listed below and together makeup the composite endpoint. * Confirmed CD4+ decline > 33% of entry and to < 350 cell/mm^3 (for participants with entry CD4+ T cell count < 700 cells/mm^3) * Confirmed CD4+ decline > 50% of entry (for participants with entry CD4+ T cell count ≥ 700 cells/mm^3) * Confirmed HIV-1 RNA level above the lower limit of quantification in the absence of an interruption of ART * New or recurrent CDC category C AIDS-indicator condition * HIV-1 associated infection including Herpes zoster * Lymphoproliferative malignancies * Grade 4 or recurrence of Grade 3 anemia/neutropenia * New diagnosis of pneumonia, sepsis, or bacteremia * Occurrence of Grade 2 or higher thrombocytopenia * Any Grade 4 or recurrence of Grade 3 toxicity Percent experiencing a safety milestone will be reported.
Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 5
Time frame: Entry to Week 5
Events defined as safety milestones are listed below. * Confirmed CD4+ decline > 33% of entry and to < 350 cell/mm^3 (for participants with entry CD4+ T cell count < 700 cells/mm^3) * Confirmed CD4+ decline > 50% of entry (for participants with entry CD4+ T cell count ≥ 700 cells/mm^3) * Confirmed HIV-1 RNA level above the lower limit of quantification in the absence of an interruption of ART * New or recurrent CDC category C AIDS-indicator condition * HIV-1 associated infection including Herpes zoster * Lymphoproliferative malignancies * Grade 4 or recurrence of Grade 3 anemia/neutropenia * New diagnosis of pneumonia, sepsis, or bacteremia * Occurrence of Grade 2 or higher thrombocytopenia * Any Grade 4 or recurrence of Grade 3 toxicity Percent experiencing each safety milestone will be reported. Safety milestone categories are not mutually exclusive.
Number of Participants With Premature Discontinuation of Study Treatment in the Ruxolitinib Arm
Time frame: Entry to Week 5
Number of participants with premature discontinuation of study treatment are summarized.
Fold Change in the Level of Plasma Interleukin 6 (IL-6) From Baseline to Week 4/5
Time frame: Pre-entry, Entry, Weeks 4 and 5
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Baseline is defined as the geometric mean of the Pre-entry and Entry values. Week 4/5 is defined as the geometric mean of the Week 4 and Week 5 values. Fold change was calculated as the value at Week 4/5 divided by the value at Baseline.
68 secondary outcomes
Percentage of Participants on the Ruxolitinib Arm Who Experienced Any Safety Milestone Events During Total Follow-up
Time frame: Entry to Week 12
Percentage of Participants Who Experienced Any Safety Milestones On-study From Entry to Week 12
Time frame: Entry to Week 12
Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 12
Time frame: Entry to Week 12
Number of Participants Who Experienced a Protocol-defined Reportable Adverse Event at Any Post-entry Time Point.
Time frame: Entry to Week 12
Creatinine Clearance
Time frame: Entry, Weeks 1, 2, 4, 5, 10, and 12
Change in Creatinine Clearance Values From Entry
Time frame: Entry, Weeks 1, 2, 4, 5, 10, and 12
Creatinine
Time frame: Entry, Weeks 1, 2, 4, 5, 10, and 12
Change in Creatinine Values From Entry
Time frame: Entry, Weeks 1, 2, 4, 5, 10, and 12
Absolute Neutrophil Count (ANC)
Time frame: Entry, Weeks 1, 2, 4, 5, 10, and 12
Change in Absolute Neutrophil Count (ANC) Values From Entry
Time frame: Entry, Weeks 1, 2, 4, 5, 10, and 12
Hemoglobin
Time frame: Entry, Weeks 1, 2, 4, 5, 10, and 12
Change in Hemoglobin Values From Entry
Time frame: Entry, Weeks 1, 2, 4, 5, 10, and 12
Platelet Count
Time frame: Entry, Weeks 1, 2, 4, 5, 10, and 12
Change in Platelet Counts From Entry
Time frame: Entry, Weeks 1, 2, 4, 5, 10, and 12
Aspartate Aminotransferase (AST) (SGOT)
Time frame: Entry, Weeks 1, 2, 4, 5, 10, and 12
Change in Aspartate Aminotransferase (AST) (SGOT) Values From Entry
Time frame: Entry, Weeks 1, 2, 4, 5, 10, and 12
Alanine Aminotransferase (ALT) (SGPT)
Time frame: Entry, Weeks 1, 2, 4, 5, 10, and 12
Change in Alanine Aminotransferase (ALT) (SGPT) Values From Entry
Time frame: Entry, Weeks 1, 2, 4, 5, 10, and 12
Fold Change in the Level of Plasma Interleukin 6 (IL-6)
Time frame: Pre-entry, Entry, Weeks 4, 5, 10 and 12
Fold Change in the Level of Soluble CD14 (sCD14)
Time frame: Pre-entry, Entry, Weeks 4, 5, and 12
Change in CD4+ T Cell Count
Time frame: Pre-entry, Entry, Weeks 2, 5, and 12
Number of Participants With Plasma HIV-1 RNA Level Above the Limit of Quantification
Time frame: Entry, Weeks 2, 5, and 12
Relative Risks of HIV-1 RNA by Single Copy Assay (SCA) < 0.4 Copies/mL
Time frame: Entry, Weeks 5 and 12
Fold Change in the Level of Plasma Tumor Necrosis Factor Alpha (TNF Alpha)
Time frame: Entry, Weeks 5 and 12
Fold Change in the Level of Plasma Interleukin 1 Beta (IL-1 Beta)
Time frame: Entry, Weeks 5 and 12
Fold Change in the Level of Plasma Interleukin 7 (IL-7)
Time frame: Entry, Weeks 5 and 12
Fold Change in the Level of Interleukin 1 Alpha (IL-1 Alpha)
Time frame: Pre-entry, Entry, Weeks 4, 5, and 12
Fold Change in the Level of Interferon Gamma-induced Protein 10 (IP-10)
Time frame: Pre-entry, Entry, Weeks 4, 5, and 12
Fold Change in the Level of Macrophage Colony-stimulating Factor
Time frame: Pre-entry, Entry, Weeks 4, 5, and 12
Fold Change in the Level of Neopterin
Time frame: Pre-entry, Entry, Weeks 4, 5, and 12
Fold Change in the Level of Plasma Interleukin 10 (IL-10)
Time frame: Entry, Weeks 5 and 12
Fold Change in the Level of Plasma Interleukin 15 (IL-15)
Time frame: Entry, Weeks 5 and 12
Fold Change in the Level of Plasma Interleukin 18 (IL-18)
Time frame: Entry, Weeks 5 and 12
Fold Change in the Level of Plasma Transforming Growth Factor Beta 1 (TGF Beta-1)
Time frame: Entry, Weeks 5 and 12
Fold Change in the Level of Plasma Transforming Growth Factor Beta 2 (TGF Beta-2)
Time frame: Entry, Weeks 5 and 12
Fold Change in the Level of Plasma Transforming Growth Factor Beta 3 (TGF Beta-3)
Time frame: Entry, Weeks 5 and 12
Change in (CD3+CD4+) CD38+HLADR+
Time frame: Entry, Weeks 5 and 12
Change in (CD3+CD8+) CD38+HLADR+
Time frame: Entry, Weeks 5 and 12
Change in (CD3+CD4+) CD25hi+
Time frame: Entry, Weeks 5 and 12
Change in (CD3+CD8+) CD25+
Time frame: Entry, Weeks 5 and 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33693561Marconi VC, Moser C, Gavegnano C, Deeks SG, Lederman MM, Overton ET, Tsibris A, Hunt PW, Kantor A, Sekaly RP, Tressler R, Flexner C, Hurwitz SJ, Moisi D, Clagett B, Hardin WR, Del Rio C, Schinazi RF, Lennox JJ. Randomized Trial of Ruxolitinib in Antiretroviral-Treated Adults With Human Immunodeficiency Virus. Clin Infect Dis. 2022 Jan 7;74(1):95-104. doi: 10.1093/cid/ciab212.
- DAIDS AE Grading Table, Version 2.0, November 2014Link provided by the sponsor.
- Version 2.0 of the DAIDS EAE ManualLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Marconi, MD study chair
Emory University
Jeffrey Lennox, MD study chair
Emory University
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ruxolitinib in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants on the Ruxolitinib Arm Who Experienced Any Safety Milestone Events While On-Treatment (time frame: Entry to Week 5). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02475655, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021.